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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K902867
Device Name CHEM-CHEX BILIRUBIN
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact HALVOR SORNSON
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact HALVOR SORNSON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/29/1990
Decision Date 07/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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